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Official Title

A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors

Phase
Phase 1
Sponsor
Xencor, Inc.
Enrollment
212
Timeline
Apr 2024 → Dec 2028
About This Study

The primary purpose of this study is to determine whether the investigational drug XmAb541 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. The study will also evaluate the effect of XmAb541 on tumor outcomes.

Eligibility Criteria

Inclusion Criteria

  • 1Age ≥ 18 years. For subjects with GCTs, age ≥15 years
  • 2CLDN6+ tumor
  • 3Histological or cytological documentation of locally advanced, recurrent, or metastatic ovarian, fallopian tube, or peritoneal cancer, adenocarcinoma of the endometrium (endometrial cancer, uterine cancer, or carcinoma of the uterine corpus), GCT
  • 4Have documented progressive disease (PD) on standard-of-care therapies appropriate for the specific tumor type; have exhausted therapies with a survival benefit or the standard therapy has no survival benefit or proven to be ineffective, intolerable, or subject is not a candidate for such available therapy.
  • 5Eastern Cooperative Oncology Group performance status of 0-2
  • 6Life expectancy ≥ 3 months
  • 7Adequate liver, kidney, and bone marrow function

Exclusion Criteria

  • 1Prior exposure to a CLDN6 targeting product
  • 2Ovarian cancer that is platinum refractory, or has rapid progression on most recent prior ≥ second line systemic anticancer therapy
  • 3Have known active central nervous system metastases and/or carcinomatous meningitis. Patients with treated brain metastases may participate, provided they are radiologically stable.
  • 4Active known or suspected autoimmune disease
  • 5Have any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug
  • 6Clinically significant cardiovascular, pulmonary or gastrointestinal disease
  • 7Positive test for hepatitis C RNA
  • 8Positive test for hepatitis B surface antigen or hepatitis B core antibody (hBcAb)

Locations

9 sites participating in this study

Winship Cancer Institute, Emory University

Atlanta, Georgia 30322

Recruiting

Karmanos Cancer Institute

Detroit, Michigan 48201

Recruiting

The John Theruer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey 07601

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →